# K103610: Clearview Exact II Influenza a & B Test

- Pathway: 510(k) (Special)
- Applicant: Alere Scarborough, Inc D/B/A Binax, Inc.
- Decided: Jan 6, 2011 after 28 days
- Product code: PSZ (Devices Detecting Influenza A, B, And C Virus Antigens)
- Device class: 2
- Regulation: 21 CFR 866.3328
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001364 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092349: Clearview Exact II Influenza a & B Test, Inverness Medical, Inc. (2010) Summary page 1.

## Most influential descendants
- K133637: Alere Influenza a & B Test (2013), 0 descendants of its own

## Indications for use
The Clearview® Exact II Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. It is recommended that negative test results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

Source page: https://510kreport.com/device/K103610
Methodology: https://510kreport.com/methodology